Phase 4
Completed N=298
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
Source: ClinicalTrials.gov NCT01534182 ↗Enrolled (actual)
298
Serious AEs
0.7%
Results posted
Aug 2014
Primary outcomePrimary: Change in Patient-reported Treatment Satisfaction — 22.69; 13.92 scores on a scale
Summary
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient-reported Treatment Satisfaction |
22.69; 13.92 | — |
| SECONDARY Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death |
73; 26; 2; 0; 0; 0 | — |
| SECONDARY Changes in Patient-reported Effectiveness, Side Effects and Convenience |
21.57; 11.56; 26.75; 13.07; 25.38; 10.57 | — |
| SECONDARY Change in Patient-reported Depression |
-2.88; -1.86 | — |
| SECONDARY Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute) |
3.62; 1.39; 6.50; 4.30; 5.24; 0.93 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
- Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
- Male or female patients aged 18-70 years.
- An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
- Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
- Naïve to treatment with fingolimod.
Exclusion Criteria
- A manifestation of MS other than those defined in the inclusion criteria.
- A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
- History of malignancy of any organ system.
- Diagnosis of macular edema during Screening Phase.
- Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
- Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
- Patients who have received total lymphoid irradiation or bone marrow transplantation.
- History of selected immune system treatments and/or medications.
- Any medically unstable condition, as assessed by the investigator.
- Selected cardiovascular, or hepatic conditions
- Selected abnormal laboratory values.
- Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
- Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
- History of hypersensitivity to the study drug or to drugs of similar chemical classes.
- Pregnant or nursing (lactating) women.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01534182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.